Prismaflex Sets
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Prismaflex Hf20 Set |
All lots. |
PRISMAFLEX HF20 SET |
Prismaflex Hf1000 Set |
All lots. |
PRISMAFLEX HF1000 |
Prismaflex St60 Set, Prismaflex St100 Set, Prismaflex St150 Set |
All lots. |
PRISMAFLEX ST150 SET |
Issue
Baxter Corporation is issuing an urgent medical device correction for the Prismaflex sets listed. The current Prismaflex set IFU is a single booklet containing 27 translated languages, and the following products include a mistranslation in the Estonian (EESTI) IFU. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Recall start date: September 15, 2022
Additional information
Details
Gambro Industries
7 Avenue Lionel-Terray, Meyzieu, France, 69883